Method and apparatus for treating a patient by intentionally occluding a blood vessel, including method and apparatus for inducing weight loss in a patient by intentionally occluding the celiac artery

ABSTRACT

A method for inducing weight loss in a patient, the method comprising delivering an apparatus to a target area in the blood vessel. The apparatus includes a first portion for preventing migration of the apparatus from the target area within the blood vessel, and a second portion that remains implanted in the blood vessel after deployment of the apparatus at the target area in the blood vessel and is configured to selectively expand and contract to provide partial or full occlusion of the blood vessel. The method further comprises expanding the second portion of the apparatus to at least partially occlude the blood vessel, allowing a period of time to pass after deployment of the apparatus to the target area in the blood vessel, contracting the second portion, and removing at least the second portion of the apparatus from the blood vessel.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

This application claims priority under 35 U.S.C. § 120 and is adivisional of U.S. patent application Ser. No. 15/862,990, entitled“METHOD AND APPARATUS FOR TREATING A PATIENT BY INTENTIONALLY OCCLUDINGA BLOOD VESSEL, INCLUDING METHOD AND APPARATUS FOR INDUCING WEIGHT LOSSIN A PATIENT BY INTENTIONALLY OCCLUDING THE CELIAC ARTERY” and filed onJan. 5, 2018, which is a continuation of U.S. patent application Ser.No. 13/655,354, entitled “METHOD AND APPARATUS FOR TREATING A PATIENT BYINTENTIONALLY OCCLUDING A BLOOD VESSEL, INCLUDING METHOD AND APPARATUSFOR INDUCING WEIGHT LOSS IN A PATIENT BY INTENTIONALLY OCCLUDING THECELIAC ARTERY” and filed on Oct. 18, 2012, which claims the benefit ofU.S. Provisional Application No. 61/548,432, entitled “METHOD ANDAPPARATUS FOR INDUCING WEIGHT LOSS IN A PATIENT BY INTENTIONALLYOCCLUDING THE CELIAC ARTERY” and filed Oct. 18, 2011, all of which arehereby incorporated by reference in their entireties.

BACKGROUND OF THE INVENTION Field of the Invention

This invention relates to surgical methods and apparatus in general, andmore particularly to surgical and non-surgical methods and apparatus fortreating a patient by intentionally occluding a blood vessel, includinga catheter-based method and apparatus for inducing weight loss in apatient by intentionally occluding the celiac artery.

Obesity is a serious medical condition. Complications associated withobesity include hypertension, diabetes, coronary artery disease, stroke,congestive heart failure, multiple orthopedic problems, pulmonaryinsufficiency, etc. Obesity can significantly affect quality of life andcan result in a markedly decreased life expectancy.

To date, surgery is the only proven method for inducing substantiallong-term weight loss in a patient. Numerous surgical procedures anddevices have been developed to induce such weight loss, e.g., “stomachstapling”, the Roux-en-Y (“The Roux”) bypass procedure, the verticalbanded gastroplasty (“VBG”) procedure, etc. However, all of the knownsurgical procedures and devices developed to date for inducing weightloss in a patient suffer from one or more significant disadvantages.

Accordingly, a new method and apparatus is needed for inducing weightloss in a patient.

SUMMARY OF THE INVENTION

The present invention provides a novel method and apparatus for inducingweight loss in a patient by intentionally occluding the celiac artery.

The present invention also provides a novel method and apparatus forinducing weight loss in a patient by intentionally occluding a bloodvessel other than the celiac artery, and/or in addition to the celiacartery.

And the present invention provides a novel method and apparatus fortreating a patient for purposes other than inducing weight loss in thepatient by intentionally occluding a blood vessel.

In one preferred form of the present invention, there is provided amethod for inducing weight loss in a patient, the method comprising:

-   -   intentionally occluding a blood vessel so as to create        hypoperfusion in a gastrointestinal organ serviced by the blood        vessel, whereby to interfere with normal gastrointestinal        function and thereby induce weight loss in a patient.

In another preferred form of the present invention, there is providedapparatus for occluding a blood vessel comprising a two-part compositestent occluder comprising (i) an exterior, endothelializing supportstent, and (ii) an interior, occluding stent comprising a loose weavefabric windsock.

In another preferred form of the present invention, there is providedapparatus for occluding a blood vessel comprising a two-part compositestent occluder comprising (i) an exterior, endothelializing supportstent, and (ii) an interior, progressively-occluding element.

In another preferred form of the present invention, there is provided amethod for providing treatment to a patient, the method comprising:

-   -   intentionally occluding a blood vessel so as to create        hypoperfusion in tissue serviced by the blood vessel, whereby to        interfere with tissue function and thereby treat the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIG. 1 is a schematic view showing one preferred location for occludingthe celiac artery in order to induce weight loss in a patient;

FIG. 2 is a schematic view showing a ligating suture for occluding theceliac artery (or other target blood vessel) and thereby inducing weightloss in a patient;

FIG. 3 is a schematic view showing a ligating clip for occluding theceliac artery (or other target blood vessel) and thereby inducing weightloss in a patient;

FIG. 4 is a schematic view showing an occluding stent for occluding theceliac artery (or other target blood vessel) and thereby inducing weightloss in a patient;

FIG. 4A is a sectional view taken along line 4A-4A of FIG. 4;

FIG. 5 is a schematic view showing an occluding umbrella device foroccluding the celiac artery (or other target blood vessel) and therebyinducing weight loss in a patient;

FIG. 5A is a sectional view taken along line 5A-5A of FIG. 5;

FIG. 6 is a schematic view showing a two-part composite stent occluderfor occluding the celiac artery (or other target blood vessel) andthereby inducing weight loss in a patient;

FIGS. 7-10 are schematic views showing deployment of the two-partcomposite stent occluder of FIG. 6;

FIGS. 11-13 are schematic views showing withdrawal of the two-partcomposite stent occluder of FIG. 6;

FIG. 14 is a schematic view showing a modified form of the two-partcomposite stent occluder of FIG. 6;

FIGS. 15 and 16 are schematic views showing another two-part compositestent occluder for occluding the celiac artery (or other target bloodvessel) and thereby inducing weight loss in a patient; and

FIGS. 17 and 18 are schematic views showing the two-part composite stentoccluder of FIGS. 15 and 16 closing down so as to occlude a bloodvessel.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention provides a novel method and apparatus for inducingweight loss in a patient by intentionally occluding the celiac artery.

The present invention also provides a novel method and apparatus forinducing weight loss in a patient by intentionally occluding a bloodvessel other than the celiac artery, and/or in addition to the celiacartery.

And the present invention provides a novel method and apparatus fortreating a patient for purposes other than inducing weight loss in thepatient by intentionally occluding a blood vessel.

Inducing Weight Loss in a Patient by Intentionally Occluding the CeliacArtery and/or Other Blood Vessels

In one preferred form of the present invention, weight loss is inducedin a patient by intentionally occluding the celiac artery in order tocreate hypoperfusion in the stomach, whereby to induce weight loss inthe patient.

More particularly, the celiac artery supplies oxygenated blood to thestomach, liver, pancreas, spleen and to the superior half of theduodenum. The celiac artery is a major source of blood for the stomach,inasmuch as the other blood vessels supplying nourishment to the stomachprovide adequate flow to maintain viability, but cannot provide themarked increase in blood flow seen in the post-prandial period.

Accordingly, in one form of the present invention, the celiac artery isintentionally reversibly occluded gradually over time in order to createhypoperfusion in the stomach (and/or other gastrointestinal organsserviced by the celiac artery) so as to interfere with normalgastrointestinal function and thereby induce weight loss in the patient.Occlusion is preferably effected at a location where it will onlyinterfere with gastrointestinal function and will not seriously impedeother essential anatomical functions. By way of example but notlimitation, and looking now at FIG. 1, occlusion may be effected in thetrunk of the celiac artery, e.g., at the location 5 shown in FIG. 1.

Alternatively, occlusion may be effected in branches of the celiacartery (e.g., the left or right gastric arteries, the left or rightgastroepiploic arteries, the common hepatic artery, and/or other celiacartery branches).

Furthermore, and also in accordance with the present invention,occlusion may be intentionally induced in other blood vessels servicingthe organs of the gastrointestinal tract, whereby to impede normalgastrointestinal function and thereby induce weight loss in the patient.By way of example but not limitation, occlusion may be intentionallyinduced in other mesenteric vessels (e.g., the superior mesentericartery and/or its major branches), and/or mesenteric veins, etc.

In essence, the present invention comprises the intentional occlusion ofsubstantially any blood vessel servicing the gastrointestinal tract suchthat the occlusion diminishes normal gastrointestinal function, wherebyto induce weight loss in the patient. One preferred form of the presentinvention comprises the intentional occlusion of the celiac artery(including one or more of its branches) so as to diminishgastrointestinal function and thereby induce weight loss in the patient.

External Occluding Devices:

Occlusion may be effected by constricting blood flow through the targetblood vessel using an external occluding device, i.e., by applying anexternal occluding device against the outer surf ace of the blood vesseland causing the blood vessel to close down so as to occlude its internallumen.

By way of example but not limitation, and looking now at FIG. 2, thetarget blood vessel may be occluded using a ligating suture 10comprising a knot 15. By way of further example but not limitation, andlooking now at FIG. 3, the target blood vessel may be occluded using aligating clip 20.

Or the target blood vessel may be occluded using other externaloccluding devices which will be apparent to those skilled in the art inview of the present disclosure.

With such external occluding devices, occlusion is preferably effectedby deploying the external occluding device against the exterior surfaceof the target blood vessel via minimally invasive (e.g., laparoscopic)surgery.

Internal Occluding Devices:

Occlusion may also be effected by constricting blood flow through thetarget blood vessel using an internal occluding device, i.e., bydeploying an internal occluding device within the internal lumen of ablood vessel so as to restrict blood flow through the internal lumen ofthe blood vessel.

By way of example but not limitation, and looking now at FIGS. 4 and 4A,the target blood vessel may be occluded using an occluding stent 25which comprises an occluding element 30 which intrudes across the lumenof the blood vessel which receives the occluding stent 25.

By way of further example but not limitation, and looking now at FIGS. 5and 5A, the target blood vessel may be occluded using an erectable“occluding umbrella” device 35 which spans the lumen of the bloodvessel.

Or, and looking now at FIG. 6, the target blood vessel may be occludedusing a two-part composite stent occluder 40 comprising (i) an exterior,endothelializing support stent 45 (e.g., comprising a skeleton 50covered by fabric 55), and (ii) an interior, removable occluding stent60 (e.g., comprising a skeleton 65 containing a loose weave fabric“windsock” 70 for clotting off with blood and thereby occluding theblood vessel). In this form of the invention, and looking now at FIGS.7-10, the exterior endothelializing support stent 45 is deployed in thetarget blood vessel (e.g., the celiac artery) first, and then theinterior occluding stent 60 is thereafter deployed within (and removablymounted to) the exterior endothelializing support stent 45, with theinterior occluding stent 60 thereafter clotting off over time. Thisconstruction has the advantage that the interior occluding stent 60 canbe readily removed from the blood vessel at a later time, whereby torestore blood flow through the blood vessel. See, for example, FIGS.11-13, which show withdrawal of the interior occluding stent 60 from thetarget blood vessel (e.g., the celiac artery).

FIG. 14 shows a variation of the two-part composite stent occluder ofFIGS. 6-13, wherein the interior occluding stent 60 comprises theaforementioned skeleton 65 and an inflatable occluding balloon 75 whichis disposed within skeleton 65. In this form of the invention, interioroccluding stent 60 is preferably removably disposed within the exteriorendothelializing support stent 45.

Or the target blood vessel may be occluded using other internaloccluding devices which will be apparent to those skilled in the art inview of the present disclosure.

With such internal occluding devices, occlusion is preferably effectedby positioning the internal occluding device within the target bloodvessel via an endoluminal approach.

Partial or Total Occlusion:

Occlusion of the target blood vessel may be partial or total. Whereocclusion is to be partial, the occluding device is configured so as topermit the creation of a partial occlusion, e.g., the ligating suture 10of FIG. 2 and/or the ligating clip 20 of FIG. 3 may be configured toapply just enough force to reduce, but not completely block, blood flowthrough the target blood vessel; and/or the occluding stent 25 of FIGS.4 and 4A, and/or the erectable “occluding umbrella” device of FIGS. 5and 5A, and/or the two-part composite stent occluder 40 of FIGS. 6-13,and/or the two part composite stent occluder 40 of FIG. 14, may beconfigured to reduce, but not completely block, blood flow through thetarget blood vessel. By way of example but not limitation, with theoccluding stent 25 of FIGS. 4 and 4A, occluding element 30 may includeholes 80, and with umbrella device 35 of FIGS. 5 and 5A, the umbrelladevice may include holes 85. Furthermore, with the two-part compositestent occluder 40 of FIGS. 6-13, the loose weave fabric “windsock” 70may be configured to clot off only a portion of the lumen of the bloodvessel, and/or with the two-part composite stent occluder 40 of FIG. 14,inflatable occluding balloon 7S may be configured to close off only aportion of the lumen of the blood vessel.

Permanent or Temporary Occlusion:

Occlusion may be permanent or temporary. Where occlusion is to betemporary, the occluding device (e.g., the ligating suture 10 of FIG. 2,the ligating clip 20 of FIG. 3, the occluding stent 25 of FIGS. 4 and4A, the erectable “occluding umbrella” device 3S of FIGS. 5 and 5A,and/or the internal component of the two-part composite stent occluder40 of FIGS. 6-13 and/or FIG. 14) may be configured so that the occludingdevice is removable at some time in the future, so that normal bloodflow through the target blood vessel may be restored. Alternatively,some or all of the occluding devices may be formed out of abiodegradable or bioabsorbable material, so that the occluding devicewill automatically cease its occlusive function at some time in thefuture.

Adjusting the Degree of Occlusion Over Time:

The degree of occlusion may also be adjusted over time. By way ofexample but not limitation, the degree of occlusion may be increasedand/or decreased over time, in order to adjust the level ofhypoperfusion created in the stomach (and/or other gastrointestinalorgan), whereby to selectively adjust the gastrointestinal function ofthe patient. Thus, if the patient is found to be losing too much weight,the degree of occlusion may be reduced so as to increasegastrointestinal function. Correspondingly, if the patient is found tobe losing too little weight, the degree of occlusion may be increased soas to further decrease gastrointestinal function. By way of example butnot limitation, a total occlusion may subsequently be partiallyre-opened or fully re-opened, a partial narrowing can be made more orless restrictive, a restrictive narrowing can be made totally occlusive,etc.

It is anticipated that different patients will require or toleratedifferent degrees of narrowing of the target blood vessel. It is alsoanticipated that patients will generally tolerate greater degrees ofnarrowing, or better tolerate complete occlusion, if the narrowing isestablished gradually. This is because gradual occlusion would allow thehypoperfused organ to produce humoral factors to recruit collateralcirculation from the adjacent anatomy. This is certainly the caseelsewhere in the body where vascular compromise occurs over a prolongedinterval, and it is anticipated that it would also be true whereocclusion is intentionally created to reduce gastrointestinal function.

Thus, an occluding device that causes slow progressive occlusion overtime may be highly desirable. In one form of the invention, where theoccluding device is an external occluding device, this progressiveoccluding device could be an encircling suture 10 (FIG. 2) and/orligating clip 20 (FIG. 3) containing a hygroscopic material (e.g.,Ameroid or the like)—the progressive occluding device could be placedlaparoscopically about the exterior surface of the target blood vessel,and the hygroscopic material would then swell over time, resulting in arelatively slow, progressive occlusion of the target blood vessel. Inanother form of the invention, where the occluding device is an internaloccluding device, the progressive occluding device could be an occludingstent 25 (FIGS. 4 and 4A) and/or an occluding umbrella device 35containing hygroscopic material that would slowly swell over time,ultimately resulting in vessel narrowing or even complete vesselocclusion. In still another form of the invention, the progressiveoccluding structure could be a stent containing a diaphanous fiber meshthat slowly clots off and/or endothelializes off over time and becomesocclusive—see, for example, the interior occluding stent 60 of FIGS.6-13, which clots off over time. In these and similar dynamic therapies,the narrowing or occlusive process is initiated at the time ofintervention, but takes place over a gradual period of time, the lengthof which is determined by the nature, design and materials of theprogressive occluding device.

Reversing Occlusion:

The ability to reverse the occlusion or narrowing of the target bloodvessel may be important in many situations. In one form of theinvention, where the occluding device is an external occluding device,the physician could use laparoscopic instruments to remove theexternally compressive or restrictive device (e.g., the encirclingsuture 10 of FIG. 2, the ligating clip 20 of FIG. 3, etc.) at a timedetermined to optimize patient benefit and minimize adverse outcomes. Inanother form of the invention, where the occluding device is an internaloccluding device, the physician could use catheters, wires andinflatable balloons to re-open an occluding stent (e.g., the occludingstent 25 of FIGS. 4 and 4A), occluding umbrella (e.g., the occludingumbrella device 35 of FIGS. 5 and 5A), endothelialized stent (e.g., withthe two-part composite stent occluder 40 of FIGS. 6-13, or with thetwo-part composite stent occlude 40 of FIG. 14, the interior occludingstent could be removed), etc. In still another form of the presentinvention, however, the therapy would spontaneously, autonomously andprogressively reverse due to the use of biodegradable or bioabsorbablecomponents in the external occluding device and/or the internaloccluding device.

In one example of a reversible intra-arterial device, the occludingdevice comprises the two-part composite stent occluder 40 of FIGS. 6-13in which an exterior stent is first placed in the target blood vessel,with an interior occluding (or gradually occluding) fabric-covered stentthereafter being placed coaxially within the exterior endothelializingsupport stent (see FIGS. 7-10). The interface between the two componentscould be designed to block tissue in-growth, so that the two stentscould be readily separated at a later time. During a subsequentintervention, the interior occluding stent would be removed (forexample, collapsed down into a catheter) and the exteriorendothelializing support stent would stay behind in the patientindefinitely (see FIGS. 11-13).

Two-Part Composite Stent Occluder Comprising Hygroscopic Material

Looking next at FIGS. 15-18, there is shown a two-part composite stentoccluder 90. More particularly, and looking now at FIG. 15, two-partstent occluder 90 comprises an exterior, endothelializing support stent95 and an interior, progressively-occluding element 100 which togetherform a generally tubular structure having a central lumen 105 extendingtherethrough.

Still looking now at FIG. 15, exterior, endothelializing support stent95 preferably comprises a cylindrical Nitinol skeleton 110 covered byfabric 115.

Looking next at FIGS. 15 and 16, interior, progressively-occludingelement 100 preferably comprises an envelope 120 formed in the shape ofa hollow cylinder and comprising (i) an exterior wall 125 connected toexterior, endothelializing support stent 95, (ii) an interior wall 130spaced from exterior wall 125, (iii) a first end seal 135, and (iv) asecond end seal 140, whereby to define a cylindrical chamber 145 betweenexterior and interior walls 125, 130 and first end seal 135 and secondend seal 140. Chamber 145 is filled with a hygroscopic material 150(e.g., a shape memory polymer which can absorb many times its own volumein water, so as to thereby dramatically increase in volume).

Envelope 120 is preferably formed out of a water-impermeable materialsuch as ePTFE (e.g., 2-4 mils thick), and includes a plurality of tinyholes 155 (e.g., 0.05 mils in diameter). Tiny holes 155 permit water(but little else) to very slowly penetrate into chamber 145 and mix withhygroscopic material 150, whereby to expand the volume of thehygroscopic material 150, as will hereinafter be discussed.

In use, and looking now at FIGS. 16-18, two-part stent occluder 90 isdisposed in the lumen of the blood vessel which is to be occluded (e.g.,the celiac artery) so that exterior, endothelializing support stent 95engages and is secured to the inner wall of the blood vessel. Initially,blood passes easily through lumen central 105 of two-part stent occlude90. However, over time, water in the blood of the patient passes throughthe tiny holes 155 in envelope 120 and enters chamber 145, where itcontacts hygroscopic material 150. This causes the hygroscopic material150 to slowly expand to many times its own volume, whereby toprogressively occlude the central lumen 105 of two-part stent occluder90 (see FIGS. 16-18). Thus it will be appreciated that, as a result ofthe foregoing construction, two-part stent occluder 90 can occlude ablood vessel so as to treat a patient (e.g., for weight loss), and thisocclusion can be effected on a gradual basis.

If it should thereafter be desired to re-open the occluded blood vessel,a conventional plastically deformable balloon expandable metallic stent(not shown), or any other appropriate stent or stent-like device, may bedeployed within the central lumen 105 of the occluded two-part stentoccluder 90. As the conventional plastically deformable balloonexpandable metallic stent is expanded, it engages the narrowed interiorwall 130 of envelope 120 and drives it radially outward with substantialforce. This action applies a compressive force to the water-swollenhygroscopic material 145, thereby forcing water out of the hygroscopicmaterial 145 (e.g., in the manner of squeezing a sponge). By applying asubstantial force in a rapid manner, first end seal 135 and/or secondend seal 140 of envelope 120 will rupture at predetermined zones,thereby allowing the hygroscopic material 145 to rapidly compress to itsoriginal volume, whereby to restore lumen 105 of two-part stent occluder90 to its open condition, with the conventional plastically deformableballoon expandable metallic stent holding the lumen open.

Creating Hypoperfusion in Other Organs Via the Intentional Occlusion ofBlood Vessels

It should be appreciated that hypoperfusion may also be created in otherorgans via the intentional occlusion of blood vessels, e.g.,hypoperfusion may be created in tumors via the intentional occlusion ofthe blood vessels servicing those tumors, in order to eradicate orreduce the tumor. In this case, the blood vessel(s) serving the tumor is(are) intentionally occluded, e.g., in the manner discussed above.Uterine fibroids, gastric and/or pancreatic tumors, bleeding gastricand/or duodenal ulcers, etc. are all candidates for the occlusiontherapy of the present invention. Still other applications will beapparent to those skilled in the art in view of the present invention.

Modifications of the Preferred Embodiments

It should be understood that many additional changes in the details,materials, steps and arrangements of parts, which have been hereindescribed and illustrated in order to explain the nature of the presentinvention, may be made by those skilled in the art while still remainingwithin the principles and scope of the invention.

What is claimed is:
 1. A method of at least partially occluding a bloodvessel, the method comprising the steps of: delivering an apparatus to atarget area in the blood vessel, the apparatus comprising: a firstportion for preventing migration of the apparatus from the target areawithin the blood vessel; and a second portion that remains implanted inthe blood vessel after deployment of the apparatus at the target area inthe blood vessel and is configured to selectively expand and contract toprovide partial or full occlusion of the blood vessel; expanding thesecond portion to at least partially occlude the blood vessel; allowinga period of time to pass after deployment of the apparatus to the targetarea in the blood vessel; contracting the second portion; and removingat least the second portion of the apparatus from the blood vessel. 2.The method of claim 1, wherein the first portion comprises a stent. 3.The method of claim 1, wherein the second portion comprises a balloon.4. The method of claim 1, wherein the blood vessel is the celiac artery.5. The method of claim 4, wherein the target area is a trunk of theceliac artery.
 6. The method of claim 1, wherein the blood vessel isselected from the group consisting of the left gastric artery, the rightgastric artery, the left gastroepiploic artery, the right gastroepiploicartery, the common hepatic artery and other celiac artery branches.